BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 4760315 · Received May 8, 2015

    Report

    Report Number
    2938836-2015-04603
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 27, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). THE REPORTED BACKUP VVI WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND AN ANOMALOUS COMPONENT ON THE HYBRID WAS BELIEVED TO BE THE CAUSE OF THE REPORTED BACKUP VVI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE WHILE STILL IN THE BOX. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303596 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1